Capsule camera clinical trials begin this month

The developers of the innovative “gut cam” will begin clinical testing this month, and have picked ShellCase of Jerusalem to design a package for the miniature technology.

An announcement in June (SCAN 6/7/00) that researchers have devised a miniature camera-in-a-capsule, dubbed the “M2A,” that can traverse the entire digestive system made big news, but the revolutionary imaging technology is several years away from the market.

The ultra-small image sensor, which was developed by Pasadena, CA-based Photobit and is being produced by Given Imaging of Yoqneam, Israel, is 1 inch long and one-third of an inch in diameter, and will be contained in an ingestible capsule that is swallowed like a pill.

Patients will wear an antenna array and a wireless recorder on a waist belt, which picks up signals transmitted by the capsule during its six-hour trip.

Given has designed a computer workstation that processes the data and produces a 20-minute video clip of the camera’s images.

Given officials said the device had passed preliminary FDA tests on animals and volunteers. The company applied for FDA approval in May. They expect the pill will cost patients about $300, while the cost to hospitals, including receptors and computer station, will be $30,000.

The ShellOP packaging technology is used for image sensors, light detection devices, and other optical applications. Given chose it because is the only package that is small enough, has good optical characteristics, and is cost-effective and simple to assemble.

When it is ready for sale, the disposable capsule camera will be marketed by Given, a developer of platform technology for GI diagnostics and therapy.